Senior Quality Assurance Manager

Tranquil Clinical and Research Consulting Services LLC; Webster (TX); On-site; USD 95,000 - 115,000; Full time

Benefits offered by this job

Autonomy in QA processes

International collaboration

Flexible working hours

Job summary

Tranquil Clinical and Research Consulting Services LLC, based in Webster, TX, seeks a Senior Quality Assurance Manager (Clinical Trials) to advance QA within a global clinical research setting. The role blends hands-on QA with cross-functional collaboration across international stakeholders.

The candidate will drive audits, CAPA, risk management and training in a GCP/FDA regulated environment, ensuring lifecycle QA from SOPs to evidence-based improvements.

Qualifications

• University degree in Life Sciences, Pharmacy, Medicine or related field.
• Several years of professional QA experience in clinical trials.
• Strong knowledge of GCP, ICH and FDA regulatory requirements.

Responsibilities

• Plan, conduct, report and track internal and external audits (process, vendor qualification, system, study audits).
• Ensure compliance with GCP, ICH, FDA and regulatory requirements.
• Own and manage Deviation and CAPA processes with root cause analysis and effectiveness checks.
• Drive risk management activities including assessments and mitigation strategies.
• Lead change management related to QA systems and clinical operations.
• Prepare QA SOPs, their review and lifecycle management.

Skills

Quality Assurance

Regulatory knowledge

Audit planning

Cross-functional collaboration

Travel availability

Education

University degree in Life Sciences/Pharmacy/Medicine

Job description

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Senior Quality Assurance Manager

Full Time Webster, TX, US

Salary Range: $95,000.00 To $115,000.00 Annually

Role Overview

We are seeking an experienced and motivated Senior Quality Assurance (QA) Manager – Clinical Trials to further develop our QA function within the clinical research environment. This role combines hands-on quality expertise with close collaboration with cross-functional and international stakeholders.

Key Responsibilities

• Plan, conduct, report and track internal and external audits (e.g. process audits, vendor qualification audits, system and study specific audits and inspections)
• Ensure compliance with GCP, ICH guidelines, FDA regulations, applicable regulatory requirements, and company standards
• Own and manage Deviation and CAPA processes, including root cause analysis, tracking, and effectiveness checks
• Drive risk management activities, including risk assessments and mitigation strategies
• Lead and support change management processes related to quality systems and clinical operations
• Responsible for the creation, review, approval, and lifecycle management of QA SOPs
• Preparation of role-based training materials and conduct of training courses in the GCP/FDA regulated setting
• Prepare quality metrics, management reports, and audit summaries for upper management
• Act as a key QA contact for regulatory inspections and sponsor audits
• Collaborate closely with Clinical Operations, Project Management, Regulatory Affairs, Data Management, Medical Writing and external partners
• Support continuous improvement initiatives within the Quality Management System (QMS)
• Review and approve validation documentation (e.g. validation plans, risk assessments, test scripts, validation reports) for computerized systems, including eQMS and other GxP-relevant systems

Qualifications & Experience

• University degree in Life Sciences, Pharmacy, Medicine, or a related field
• Several years of professional experience in Quality Assurance within clinical trials
• Strong knowledge of GCP, ICH and international regulatory requirements (e.g. FDA regulations)
• Demonstrated experience in:
• Audit planning, performance, and reporting
• Deviation and CAPA management
• Change management
• SOP and training management

· Willingness to travel nationally and internationally, particularly within/to Germany, within Europe and the USA

· Strong organizational, analytical, and problem-solving skills

· Confident communication style and ability to work with stakeholders at all levels

What We Offer

• A responsible senior role in an international clinical research environment
• High level of autonomy and the opportunity to actively shape QA processes
• Collaboration with global teams and exposure to international projects
• A thorough and practice-oriented onboarding
• Performance-based compensation and flexible working hours
• A company culture strongly characterized by trust and collegiality
• An exciting workplace with opportunities for professional and personal development, for example development into a team lead function